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A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer


OBJECTIVES:

Primary

- To test the hypothesis that laparoscopic-assisted resection is not inferior to open
resection, based on a composite primary endpoint of oncologic factors that are
indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA,
or IIIB rectal cancer.

Secondary

- To compare the patient-related benefit of laparoscopic-assisted resection vs open
resection, in terms of blood loss, length of stay, and utilization of pain medication.

- To compare the disease-free survival and local pelvic recurrence at 2 years.

- To compare the quality of life, sexual function, and bowel and stoma function.

OUTLINE: This is a multicenter study. Patients are stratified according to site of primary
tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure
(low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo open laparotomy and rectal resection.

- Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is
assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and
-CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale
(SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ).

After completion of study treatment, patients are followed periodically for up to 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the rectum (≤ 12 cm from the anal verge)

- T3, N0, M0 or T1-3, N1-2, M0 disease by pre-neoadjuvant therapy CT scans and
pelvic MRI or transrectal ultrasound

- No T4 disease

- Must have completed neoadjuvant fluorouracil-based chemotherapy and/or radiotherapy
within the past 4 weeks

- Capecitabine may have been substituted for fluorouracil

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Body mass index ≤ 34

- Negative pregnancy test

- No evidence of conditions (e.g., multiple prior major laparotomies or severe
adhesions) that would preclude use of a laparoscopic approach

- No systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude
surgery

- No other severe incapacitating disease (i.e., ASA IV [severe systemic disease that is
a constant threat to life] or ASA V [moribund and is not expected to survive without
the operation])

- No other invasive pelvic malignancy (cervical, uterine, or rectal) within the past 5
years

- No history of psychiatric or addictive disorders or other conditions that, in the
opinion of the investigator, would preclude the patient from meeting the study
requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Circumferential margin > 1 mm

Safety Issue:

No

Principal Investigator

James W. Fleshman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

Unspecified

Study ID:

CDR0000601816

NCT ID:

NCT00726622

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IIA rectal cancer
  • stage IIIA rectal cancer
  • stage IIIB rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Overlook HospitalSummit, New Jersey  07902-0220
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
California Pacific Medical Center - California CampusSan Francisco, California  94118
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
John B. Amos Cancer CenterColumbus, Georgia  31904
Evanston HospitalEvanston, Illinois  60201-1781
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Duke Cancer InstituteDurham, North Carolina  27710
Veterans Affairs Medical Center - IndianapolisIndianapolis, Indiana  46202
Cleveland Clinic Florida - WestonWeston, Florida  33331
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Boone Hospital CenterColumbia, Missouri  65201
Kendrick Regional Center for Colon and Rectal Care - MooresvilleMooresville, Indiana  46158
Blodgett Hospital at Spectrum HealthGrand Rapids, Michigan  49506
INTEGRIS Cancer Institute of Oklahoma - Proton CampusOklahoma City, Oklahoma  73142
Forbes Regional HospitalMonroeville, Pennsylvania  15146
Clarian North Medical CenterCarmel, Indiana  46032